CT-322 in Treating Patients With Recurrent Glioblastoma Multiforme and Combination Therapy With Irinotecan
Part of paid clinical trials in La Jolla, California.
- Sponsor
- Adnexus, A Bristol-Myers Squibb R&D Company
- Study ID
- NCT00562419
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Brain and Central Nervous System Tumors
- Recurrent Glioblastoma Multiforme
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CT-322 — DRUGIV solution, weekly
- irinotecan hydrochloride — DRUGIV solution, biweekly
Study Details
RATIONALE: CT-322 may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving CT-322 together with irinotecan may kill more tumor cells. PURPOSE: This phase 2 trial is studying the side effects, tolerability, and efficacy of CT-322 when given alone and in combination with irinotecan to patients with glioblastoma multiforme.
Key Dates
- Start date
- Oct 31, 2007
- Status verified
- Oct 2010
- Primary completion
- Jun 30, 2011
- Completion
- Dec 31, 2011
Study Design
- Enrollment
- 72 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 1CT-322
- Experimental: 2CT-322 and irinotecan hydrochloride
Primary Outcome Measure
Safety and tolerability of CT-322 when administered alone or in combination with irinotecan hydrochloride (Part 1) [ Time Frame: 15 ± 5 days post the last dose of study drug ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037-0845 | - |
| University of Kentucky | Lexington | Kentucky | 40536 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02114 | - |
| Henry Ford Health System | Detroit | Michigan | 48202 | - |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | - |
| Duke University Medical Center | Durham | North Carolina | 27710 | - |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | - |
| MD Anderson Cancer Center | Houston | Texas | 77030 | - |
| University of Virgina | Charlottesville | Virginia | 22908 | - |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | - |
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